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Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Newly diagnosed, Early stage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Must undergo definitive local therapy with either breast conserving therapy or mastectomy
  • Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
  • Able to undergo breast MRI

Exclusion Criteria:

  • Not pregnant or breastfeeding
  • No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
  • No prior mantle radiation
  • No locally advanced breast cancer
  • No diffuse malignant appearing microcalcifications requiring mastectomy
  • No known collagen vascular disease
  • No previous ipsilateral radiation
  • No participants who undergo surgery at an outside institution
  • No prior history of breast carcinoma

Sites / Locations

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Faulkner Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

MRI

No MRI

Arm Description

MRI

No MRI

Outcomes

Primary Outcome Measures

Assess if pre-operative MRI reduces incidence of re-excisions required
Assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma

Secondary Outcome Measures

Total Mastectomy Rates
Total Mastectomy Rates
Number of biopsies
The number of biopsies recommended and performed
Local-regional recurrence rates
Local-regional recurrence rates in participants undergoing local therapy
Time from diagnosis to local therapy
The time from diagnosis to definitive local therapy
Number of malignancies in contralateral breast
The number of malignancies identified int he contralateral breast

Full Information

First Posted
March 29, 2012
Last Updated
August 1, 2016
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01568346
Brief Title
Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy
Official Title
Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Slow Accural
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.
Detailed Description
This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results. The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Newly diagnosed, Early stage

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI
Arm Type
Active Comparator
Arm Description
MRI
Arm Title
No MRI
Arm Type
No Intervention
Arm Description
No MRI
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Breast MRI
Primary Outcome Measure Information:
Title
Assess if pre-operative MRI reduces incidence of re-excisions required
Description
Assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Total Mastectomy Rates
Description
Total Mastectomy Rates
Time Frame
2 years
Title
Number of biopsies
Description
The number of biopsies recommended and performed
Time Frame
2 years
Title
Local-regional recurrence rates
Description
Local-regional recurrence rates in participants undergoing local therapy
Time Frame
2 years
Title
Time from diagnosis to local therapy
Description
The time from diagnosis to definitive local therapy
Time Frame
2 years
Title
Number of malignancies in contralateral breast
Description
The number of malignancies identified int he contralateral breast
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must undergo definitive local therapy with either breast conserving therapy or mastectomy Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative Able to undergo breast MRI Exclusion Criteria: Not pregnant or breastfeeding No prior breast MRI for the newly diagnosed carcinoma at the outside hospital No prior mantle radiation No locally advanced breast cancer No diffuse malignant appearing microcalcifications requiring mastectomy No known collagen vascular disease No previous ipsilateral radiation No participants who undergo surgery at an outside institution No prior history of breast carcinoma
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Faulkner Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy

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